Stakeholder Consultation on the EU blood and tissues and cells legislation
Posted on 28.09.2017
The Commission is currently carrying out an evaluation of the EU blood and tissues and cells legislation (Directives 2002/98/EC and 2004/23/EC).
A stakeholder consultation, which aimed at collecting views and opinions on the implementation of the blood, tissues and cells legislation, took place on 20 September 2017.
The discussion was centred on five topics:
- The key importance of donors – The gift of life
- Regulatory oversight of the sectors – How to ensure safety and quality?
- Availability and sufficiency – Are patients getting the blood, tissues and cells that they need?
- Legal consistency and coherence – Regulatory pathways for Substances of Human Origin
- A changing world – Technological, societal, epidemiological and international developments
The stakeholder consultation alongside the submissions put forward by various organisations and relevant documents and literature will serve as a basis for a study supporting the evaluation, which will be prepared by an external contractor in Q3 2018.
The Commission will decide whether to revise the EU blood and tissues and cells legislation in Q4 2018 and its argumentation will be presented in the Commission’s evaluation report.